Sleeve Gastrectomy and Roux-en-Y Gastric Bypass in the Treatment of Type 2 Diabetes Mellitus.
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Roux-en-Y gastric bypass, sleeve gastrectomy.
- Who it may be relevant to
- Registry conditions: Obesity, Type 2 Diabetes, Bariatric Surgery. Basic parameters: 18 years — 60 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Sweden
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Sleeve Gastrectomy and Roux-en-Y Gastric Bypass in the Treatment of Type 2 Diabetes Mellitus. Randomised Controlled Trial
Overview
Obesity is a growing epidemic throughout the world and is followed by increasing incidence of type 2 diabetes that accounts for 90-95% of all cases of diabetes. Weight loss is a major objective, although difficult to achieve with medical treatments. Many recent studies demonstrated that bariatric surgery has the potency to achieve marked and sustained weight loss, and is also associated with a significant improvement in control of type 2 diabetes. The principal aim of this study is to compare two types of bariatric procedures, the Roux-en-Y gastric bypass (RYGBP) and sleeve gastrectomy (SG). The study hypothesis is that these procedures have equal efficacy with regard to resolution of type 2 diabetes.
Interventions
- Procedure Roux-en-Y gastric bypass
RYGBP=Roux-en-Y gastric bypass - Procedure sleeve gastrectomy
SG = sleeve gastrectomy
Primary outcome measures
- Rate of resolution of type 2 diabetes [Time frame: 5 years]
Secondary outcome measures (1)
- postoperative complications [Time frame: 5 years]
Eligibility criteria
Inclusion criteria
- Type 2 diabetes mellitus
- BMI between 35 and 50kg/m2.
- Males and females
- Age between 18 and 60 years.
Exclusion criteria
- Severe ongoing psychiatric disorder, alcoholism and substance abuse.
- Redo operations after previous bariatric procedures.
- Type 1 diabetes or other non-type 2 forms of diabetes
- End stage renal disease, retinopathy, neuropathy
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Sweden · 1 center
- Sahlgrenska University Hospital — Gothenburg
Identifiers
NCT: NCT01984762 · 684-11